Sunosi (solriamfetol) / Jazz, SK Bio, Uniphar, Axsome Therap, Pharmanovia - LARVOL DELTA

Axsome Therapeutics Presents Data from Three of Its Innovative Neuroscience Programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting (GlobeNewswire) - "Axsome Therapeutics, Inc...announced presentations from three of its innovative neuroscience programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting, being held from May 27-30 in Scottsdale, Arizona."

Clinical data • Alzheimer's Disease • Depression • General Anxiety Disorder • Major Depressive Disorder • Narcolepsy

Axsome Therapeutics Settles SUNOSI (solriamfetol) Patent Litigation with Hetero Labs Ltd. (The Manila Times) - "Axsome Therapeutics, Inc...announced that it has entered into a settlement agreement with Hetero Labs Ltd. and certain of its affiliates (Hetero) resolving patent litigation related to Axsome's product SUNOSI (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Hetero of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of SUNOSI in the United States. Under the terms of the settlement agreement, Axsome will grant Hetero a license to sell its generic version of SUNOSI beginning on or after September 1, 2040, if pediatric exclusivity is granted for SUNOSI, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type."

Commercial • CNS Disorders

Solriamfetol and CBT-I in Patients With Insomnia Disorder (clinicaltrials.gov) - P4 | N=60 | Active, not recruiting | Sponsor: University of Pennsylvania | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Apr 2026 | Trial primary completion date: Jul 2025 ➔ Jan 2026

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Fatigue • Insomnia • Sleep Disorder

Daily solriamfetol improved performance on a memory and attention task in people with obstructive sleep apnea and excessive daytime sleepiness: a plain language summary. (PubMed, Postgrad Med) - No abstract available

Journal • Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Axsome Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Clinical Trial Topline Results: Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2026); Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026). Clinical Trial Initiations and Progress: Pivotal Phase 2/3 trial of AXS-05 in smoking cessation, initiation (2025); Phase 3 trial of solriamfetol in ADHD in pediatric patients, initiation (2025); Phase 3 trial of solriamfetol in MDD with EDS, initiation (2025)."

New P2/3 trial • New P3 trial • P3 data: top line • Attention Deficit Hyperactivity Disorder • Binge Eating Disorder • Major Depressive Disorder

Axsome Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "AUVELITY: Approximately 167,000 prescriptions were written for AUVELITY in the first quarter of 2025, representing an increase of 76% compared to the same period in 2024, and an increase of 5% compared to the fourth quarter of 2024. Payer coverage for AUVELITY across all channels is approximately 78% of all covered lives. The proportion of lives covered for AUVELITY in the commercial and government (Medicare and Medicaid) channels are approximately 63% and 100%, respectively. SUNOSI: Approximately 46,000 prescriptions were written for SUNOSI in the U.S. in the first quarter of 2025, representing an increase of 12% compared to the same period in 2024, and a decrease of 5% compared to the fourth quarter of 2024. Payer coverage for SUNOSI across all channels is approximately 83% of all covered lives. The proportion of lives covered for SUNOSI in the commercial and government channels are approximately 95% and 60%, respectively."

Commercial • CNS Disorders • Major Depressive Disorder • Obstructive Sleep Apnea • Psychiatry • Sleep Disorder

Axsome Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "AUVELITY net product sales were $96.2 million for the first quarter of 2025, representing 80% year-over-year growth. AUVELITY net product sales for the comparable period in 2024 were $53.4 million. SUNOSI net product revenue was $25.2 million for the first quarter of 2025, representing 17% year-over-year growth, which consisted of $24.1 million in net product sales and $1.1 million in royalty revenue associated with SUNOSI sales in out-licensed territories. SUNOSI net product revenue for the comparable period in 2024 was $21.6 million, which consisted of $20.7 million in net product sales and $0.9 million in royalty revenue."

Sales • CNS Disorders • Major Depressive Disorder • Obstructive Sleep Apnea • Psychiatry • Sleep Disorder

RECOVER-SLEEP: Platform Protocol (clinicaltrials.gov) - P2 | N=1074 | Recruiting | Sponsor: Duke University | Trial completion date: Jul 2025 ➔ Dec 2025 | Trial primary completion date: Jul 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Sleep Disorder

PARADIGM: Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol (clinicaltrials.gov) - P3 | N=346 | Completed | Sponsor: Axsome Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Mar 2025 | Trial primary completion date: Dec 2025 ➔ Dec 2024

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Comparative Efficacy and Safety of Multiple Wake-Promoting Agents for the Treatment of Residual Sleepiness in Obstructive Sleep Apnea Despite Continuous Positive Airway Pressure: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. (PubMed, CNS Drugs) - "Among all WPAs, solriamfetol demonstrated the highest efficacy on ESS and MWT, with the latter being significant. Modafinil demonstrated the best clinician impression, albeit not statistically significant. All four WPAs were associated with a low risk of serious or adverse events."

Journal • Retrospective data • Review • CNS Disorders • Depression • Mood Disorders • Obstructive Sleep Apnea • Psychiatry • Respiratory Diseases • Sleep Disorder

A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (clinicaltrials.gov) - P4 | N=44 | Completed | Sponsor: Rochester Center for Behavioral Medicine | Active, not recruiting ➔ Completed | Trial completion date: May 2024 ➔ Dec 2024 | Trial primary completion date: Mar 2024 ➔ Sep 2024

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Fatigue • Infectious Disease

Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder (clinicaltrials.gov) - P4 | N=82 | Terminated | Sponsor: Charles A. Czeisler, PhD, MD | Trial completion date: Nov 2024 ➔ Apr 2024 | Recruiting ➔ Terminated; Study was stopped due to funding limitations.

Trial completion date • Trial termination

A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS) (clinicaltrials.gov) - P3 | N=516 | Completed | Sponsor: Axsome Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Mar 2025

Trial completion • Trial completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Expert consensus on the diagnosis and treatment of excessive daytime sleepiness in obstructive sleep apnea (PubMed, Zhonghua Jie He He Hu Xi Za Zhi) - "Surgical interventions can also be used as an adjunctive therapy to CPAP (2, B).Recommendation 6: OSA patients with EDS should make lifestyle changes, including correcting poor lifestyle habits and improving sleep hygiene, to improve nocturnal sleep quality and daytime alertness (3, B).Recommendation 7: Pharmacological wake-promoting agents may be considered, after careful clinical evaluation, in OSA patients who meet the following criteria: ① Residual EDS persists despite adequate and adherent conventional OSA therapy (including CPAP, oral appliances, and surgery) with exclusion of other EDS etiologies; ② Patients with EDS who refuse, are intolerant of, or are not compliant with conventional therapy; ③ Patients with EDS that severely impairs quality of life, interferes with work/study performance, or increases the risk of accidents (including those with actual or near-miss accidents) (expert consensus, ungraded).Recommendation 8: For patients with residual EDS despite..."

Journal • Cardiovascular • CNS Disorders • Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Psychiatry • Respiratory Diseases • Sleep Disorder

Axsome Therapeutics Announces FOCUS Phase 3 Trial of Solriamfetol in Adults with Attention Deficit Hyperactivity Disorder (ADHD) Achieves Primary Endpoint (GlobeNewswire) - P3 | N=450 | FOCUS (NCT05972044) | Sponsor: Axsome Therapeutics, Inc. | "Demonstrated substantial and statistically significant improvement in ADHD symptoms as measured by the AISRS total score compared to placebo (p=0.039, primary endpoint, 150 mg solriamfetol); Statistically significant reduction in overall ADHD disease severity as measured by the CGI-S score compared to placebo (p=0.017, key secondary endpoint, 150 mg solriamfetol); Statistically significant rate of clinical response on the AISRS compared to placebo (p=0.024, 150 mg solriamfetol); Onset of action as early as Week 1 compared to placebo (p=0.036, AISRS, 150 mg solriamfetol); Well tolerated with safety profile generally consistent with prior solriamfetol trials; With these results in the adult population in hand, we plan to initiate a trial in pediatric patients this year."

New trial • P3 data • Attention Deficit Hyperactivity Disorder

Management options for excessive daytime sleepiness in patients with obstructive sleep apnea. (PubMed, Expert Rev Respir Med) - "Solriamfetol and pitolisant are wake-promoting agents (WPA) recently approved for use in sleepy OSA patients accepting or refusing OSA treatment...However, it is still uncertain which subgroups of patients should be treated for the symptom of EDS while maintaining a low-risk profile in terms of consequences of OSA on health. Until such data are available, use of WPA in OSA patients should be managed by Sleep Specialists."

Journal • Review • Cardiovascular • Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Open-Label Safety Study of Solriamfetol in Subjects with Binge Eating Disorder (clinicaltrials.gov) - P3 | N=300 | Enrolling by invitation | Sponsor: Axsome Therapeutics, Inc.

New P3 trial • Binge Eating Disorder • CNS Disorders

Axsome Therapeutics Settles Sunosi (solriamfetol) Patent Litigation with Hikma Pharmaceuticals USA (GlobeNewswire) - "Axsome Therapeutics, Inc...today announced that it has entered into a settlement agreement with Hikma Pharmaceuticals USA, Inc. (Hikma) resolving patent litigation related to Axsome’s product Sunosi (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Hikma of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Under the terms of the settlement agreement, Axsome will grant Hikma a license to sell its generic version of Sunosi beginning on or after September 1, 2040, if pediatric exclusivity is granted for Sunosi, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type."

Commercial • Cataplexy • Excessive Daytime Sleepiness • Excessive Daytime Sleepiness in Narcolepsy • Narcolepsy • Obstructive Sleep Apnea • Sleep Disorder

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA) (clinicaltrials.gov) - P3 | N=204 | Completed | Sponsor: Ignis Therapeutics (Suzhou) Limited | Recruiting ➔ Completed

Trial completion • Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Patients with obstructive sleep apnea in Germany. (PubMed, Sleep Breath) - "Most patients in this study were new to therapy. Solriamfetol was typically initiated at 37.5 mg/day; titration was common. ESS scores improved with solriamfetol treatment, and most patients self-reported improvement in EDS symptoms. Common adverse events were consistent with those reported in previous clinical trials."

Journal • Retrospective data • CNS Disorders • Excessive Daytime Sleepiness • Insomnia • Obstructive Sleep Apnea • Pain • Respiratory Diseases • Sleep Disorder

Axsome Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Anticipated Milestones - Regulatory and Commercial: AXS-14 for fibromyalgia, NDA submission (1Q 2025)....AXS-12 for narcolepsy, NDA submission (2H 2025). Clinical Trial Topline Results: Phase 3 EMERGE trial of AXS-07 in migraine in patients with inadequate response to oral CGRP inhibitors (1Q 2025); Phase 3 FOCUS trial of solriamfetol in ADHD in adults (1Q 2025); Phase 3 PARADIGM trial of solriamfetol in major depressive disorder (1Q 2025); Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2026); Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026)."

P3 data: top line • Attention Deficit Hyperactivity Disorder • Binge Eating Disorder • Fibromyalgia • Major Depressive Disorder • Migraine • Narcolepsy

Axsome Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Auvelity net product sales were $92.6 million and $291.4 million for the fourth quarter and full year of 2024, representing 89% and 124% year-over-year growth, respectively. Auvelity net product sales for the comparable periods in 2023 were $49.0 million and $130.1 million, respectively. Sunosi net product revenues were $26.2 million and $94.3 million for the fourth quarter and full year of 2024, representing 16% and 26% year-over-year growth, respectively, which consisted of $24.7 million and $90.3 million in net products sales and $1.4 million and $4.0 million in royalty and milestone revenue associated with Sunosi sales in out-licensed territories, respectively."

Sales • Cataplexy • CNS Disorders • Depression • Excessive Daytime Sleepiness • Excessive Daytime Sleepiness in Narcolepsy • Major Depressive Disorder • Mood Disorders • Narcolepsy • Obstructive Sleep Apnea • Psychiatry • Sleep Disorder

Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (clinicaltrials.gov) - P2 | N=2 | Terminated | Sponsor: Wake Forest University Health Sciences | N=36 ➔ 2 | Suspended ➔ Terminated; Axsome has conducted a review of the ongoing IST program and are unable to continue supporting this study

Enrollment change • HEOR • Trial termination • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor • MGMT

Trends and variation in issuance of high-cost narcolepsy drugs by NHS England organisations and regions from 2019 to 2022. (PubMed, J Sleep Res) - "Volumes were converted to World Health Organisation defined daily doses, to estimate the monthly number of defined daily doses of sodium oxybate, pitolisant and solriamfetol issued by each integrated care board and region. Variations between integrated care boards and regions differ substantially by drug and route of issuance. Our findings describe substantial variation in the use of specialist narcolepsy drugs in England, and highlight the untapped potential of using large, public domain datasets to publicly review higher-cost drug prescribing."

Journal • Narcolepsy • Sleep Disorder

Evaluation of pitolisant, sodium oxybate, solriamfetol, and modafinil for the management of narcolepsy: a retrospective analysis of the FAERS database. (PubMed, Front Pharmacol) - "However, potential novel or notable ADE signals were identified through real-world pharmacovigilance analysis. It is anticipated that this paper will offer additional information regarding safe and rational medication for narcolepsy."

Journal • Retrospective data • CNS Disorders • Cognitive Disorders • Depression • Developmental Disorders • Immunology • Mental Retardation • Movement Disorders • Narcolepsy • Obstructive Sleep Apnea • Psychiatry • Respiratory Diseases • Restless Legs Syndrome • Sleep Apnea • Sleep Disorder • Suicidal Ideation